Glancing over at the changing development requirements for biosimilars in the US and Europe, the Chinese duo Chime Biologics and Beijing Libang Pharmaceutical are allying to develop a blinatumomab biosimilar rival to Amgen’s Blincyto.
Generics Bulletin reviews global regulatory developments across the world.
Licensing agreement expands Polpharma’s footprint in Latin America while supporting Libbs’ strategy to grow access to advanced biologics in Brazil.
Unified Patent Court ruling removes legal overhang on cabazitaxel generics already on the European market.
The FDA rejection of Alvotech’s AVT06 Eylea biosimilar was revealed as part of a wider funding update outlining a $108m bond placement and continued heavy R&D investment.
UK liquids specialist Rosemont Pharmaceuticals has named industry veteran Alok Sonig as its new CEO, as the firm continues to set its sights on the US market. Meanwhile, Rosemont has also appointed Gavin Wood as chief financial officer.
Civica has been cleared to supply essential generic medicines across the US veterans health system under a federal supply schedule agreement.
After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.
The European Commission’s pending decision for Stada-Bio-Thera could bring a second golimumab biosimilar to market, tightening competition behind Alvotech-Advanz’s early launch plans.
Sandoz said it was “asserting biosimilars leadership” as it announced the completion of a deal to acquire Just-Evotec Biologics’s Toulouse development and manufacturing site as well as an indefinite licence to the firm’s continuous manufacturing technology.
After multiple warning letter campaigns, the US FTC has claimed a win as Teva’s request to remove hundreds of Orange Book patent listings will pave a generic competition path for more than 30 products.
The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.
CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
Cipla’s rollout of Lilly’s tirzepatide second brand comes as Wegovy price cuts tighten competition in India’s fast-growing GLP-1 market.
Responding to the newly-agreed EU pharma package, Medicines for Europe said the deal was a limited political compromise that could have been more ambitious – particularly when it comes to access – but nevertheless represented “an important step forward” and “progress” for the EU pharma sector.
“Section viii cannot function as Congress intended,” if a Federal Circuit ruling stands, the US solicitor general has argued as he urged the Supreme Court to review and reverse the closely-watched Hikma skinny-label Vascepa case.
Formycon has again stepped closer to financial certainty with another pembrolizumab biosimilar deal. This time, it unlocked a significant opportunity for the US and Canadian markets.
The US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.
Teva sees olanzapine LAI as key to building a schizophrenia franchise worth up to $2bn annually, following its earlier risperidone launch.